A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors
Journal
Journal of experimental & clinical cancer research : CR
Journal Volume
41
Journal Issue
1
Date Issued
2022-06-02
Author(s)
Chan, Stephen L
Schuler, Martin
Kang, Yoon-Koo
Yen, Chia-Jui
Edeline, Julien
Choo, Su Pin
Okusaka, Takuji
Weiss, Karl-Heinz
Macarulla, Teresa
Cattan, Stéphane
Blanc, Jean-Frederic
Lee, Kyung-Hun
Maur, Michela
Pant, Shubham
Kudo, Masatoshi
Assenat, Eric
Zhu, Andrew X
Yau, Thomas
Lim, Ho Yeong
Bruix, Jordi
Geier, Andreas
Guillén-Ponce, Carmen
Fasolo, Angelica
Finn, Richard S
Fan, Jia
Vogel, Arndt
Qin, Shukui
Riester, Markus
Katsanou, Vasiliki
Chaudhari, Monica
Kakizume, Tomoyuki
Gu, Yi
Porta, Diana Graus
Myers, Andrea
Delord, Jean-Pierre
Abstract
Deregulation of FGF19-FGFR4 signaling is found in several cancers, including hepatocellular carcinoma (HCC), nominating it for therapeutic targeting. FGF401 is a potent, selective FGFR4 inhibitor with antitumor activity in preclinical models. This study was designed to determine the recommended phase 2 dose (RP2D), characterize PK/PD, and evaluate the safety and efficacy of FGF401 alone and combined with the anti-PD-1 antibody, spartalizumab.
Subjects
FGF19; FGFR4; Hepatocellular carcinoma; Immune checkpoint inhibitors; KLB; PD-1; PD-L1; Phase 1
SDGs
Type
journal article